Novel combination product

ABSTRACT

A combination product comprising a nasal spray dispenser containing a formulation for nasal administration, and a balm holder element containing a skin-care balm, attached to a bottom of the nasal spray dispenser.

CROSS REFERENCE TO PRIOR APPLICATIONS

This application claims the benefit of US Design 29/712813 filed 12 Nov.2019 which claims priority to the ECD 001471874 filed 14 May 2019, andEU 19209288.0 filed 14 Nov. 2019.

TECHNOLOGY FIELD

This invention relates to a novel combination product. The combinationproduct comprises a nasal spray product containing a formulation fornasal administration and a balm holder element containing a skin-carebalm.

BACKGROUND

Intranasal administration of a formulation, for example a drugformulation or a medicinal product formulation, frequently employs aprimary packaging for such formulation that comprises a container and adispensing mechanism with a nozzle that is suitable to be introducedinto a user's nostril and from which such formulation is dispensed intothe nostril. In particular for liquid formulations containing an activeingredient, where it is important that the desired dose of theingredient is administered, metered dose spray pumps are commonly usedas a dispensing mechanism.

Metered dose spray pumps are for example known from EP1768789B3,EP1954403B1, or WO2017191205A1. These documents are incorporated byreference.

The indications for which certain nasally administered drugs may be usedare known in the art. For example, vasoconstrictors are used as nasaldecongestants for alleviating the typical symptoms of the common cold orflu, like runny nose, obstructed nose etc., or for alleviating thesymptoms of rhinitis or sinusitis. Antiallergic agents andcorticosteroids are used in the treatment of allergic conditions, e.g.hay fever, or in asthmatic or inflammatory conditions.

Patients who suffer from any of these conditions frequently use tissuesto blow their nose or to clean their nose. This often leads to skinirritation and redness around the nose, which generally occurs soonafter the onset of the symptoms which are treated by the intranasaladministration of a formulation. This irritation or redness can even beexacerbated by the formulation which has been administered.

Today, patients and consumers either leave this skin irritationuntreated, or treat it with skin creams or balms sold separately or fordifferent purposes, and/or conceal it with make-up or other cosmeticproducts. However, the use of concealer or make-up does not treat thecondition, and might even worsen it. Furthermore, using a nasal sprayand a separate product such as a cream or balm is not convenient,especially when both products need to be used several times per day, andusers are traveling or commuting to their workplace, school or otherlocations.

Thus, there is a need for a solution allowing users to convenientlytreat the skin irritation and redness around the nose occurringfrequently together with nasal congestion or a runny nose.

SUMMARY

Aspects of the present invention are directed to a novel combinationproduct comprising a nasal spray dispenser containing a formulation fornasal administration, and a balm holder element attached to a bottom ofthe nasal spray dispenser containing a skin-care balm. According to anembodiment, the nasal spray dispenser comprises a dispensing headmounted on a top of a container.

In another embodiment, the combination product comprises a dispensinghead mounted on a top of a container containing a liquid formulation fornasal administration, and a solidified skin-care balm for applicationaround the nose contained in a balm holder element attached to a bottomof the container. In an embodiment, the balm holder element comprises abase element on which the balm is mounted, a balm cover with acylindrical portion surrounding the balm, and a cover portion.

In an embodiment, the nasal spray dispenser containing the formulationis made from high density polyethylene (HDPE). According to anembodiment of the invention, the dispensing head is a metered dose spraypump.

According to an embodiment of the invention, the balm holder elementcomprises a base element on which the balm is mounted, a balm cover witha cylindrical portion surrounding the balm, and a cover portion. Thebalm cover may be removed from the base element, exposing the balm. Thebalm is then ready to be applied directly to the skin. In an embodiment,the cylindrical portion of the balm cover is aligned with a cylindricalwall of the nasal spray dispenser containing the formulation.

According to an embodiment of the invention, the balm cover is attachedto the nasal spray dispenser. Preferably, the cover portion of the balmcover is attached to the bottom of the nasal spray dispenser.

In an embodiment, the cover portion of the balm cover is glued to thebottom of the nasal spray dispenser. In another embodiment, the balmcover is clipped or snap-fitted to the bottom of the nasal spraydispenser. Depending on the design of the connection, this can alsoallow for an assembly or disassembly by the consumer.

In an embodiment, the cover portion of the balm cover is dome-shaped andmatches a recess in the bottom of the nasal spray dispenser. Thisimproves the bond between the balm cover and the nasal spray dispenser.

According to an embodiment, the base element is attached to the bottomof the nasal spray dispenser. In an embodiment, the base element can beglued, clipped, or snap-fitted to the nasal spray dispenser, or attachedin any other suitable way, either removable or non-removable for theconsumer. In an embodiment, the balm holder element is detachablyattached to the bottom of the nasal spray dispenser.

In one embodiment, the formulation is a liquid formulation containing asaline solution. In another embodiment, the formulation is a liquidformulation containing an active ingredient selected from a group ofvasoconstrictors, antiallergic agents and corticosteroids. In oneparticular embodiment, the active ingredient is xylometazoline or apharmaceutically acceptable salt thereof.

In one embodiment, the balm comprises one or several skin conditioningagents. In an embodiment, the balm comprises an active ingredient thatis a botanical extract. In one embodiment, the botanical extract isZanthoxylum bungeanum fruit husk extract.

In one embodiment, the balm comprises a blend of two or more waxes in anamount from 15%-45% (w/w). In one embodiment, the balm further comprisesemollients in an amount from 45%-70% (w/w). In one embodiment, the blendof two or more waxes comprises a first wax having a melting point of 70°C.-90° C. and a second wax having a melting point of 30° C.-60° C. Inone embodiment, the first wax is rice bran wax. In one embodiment, thebalm has a melting point from 60° C. to 75° C.

In an embodiment, the balm has substantially a hemispherical shape.

An embodiment of the present invention is directed to a method fortreating nasal discomfort whereby a cooling and soothing effect isprovided to a perinasal skin area, comprising use of the combinationproduct according to the invention by application of the balm to theperinasal skin area and administration of the formulation for nasaladministration into a nostril.

Another embodiment of the present invention is directed to a method fortreating runny nose whereby irritated skin is soothed, comprising use ofa combination product according to the invention by application of thebalm to an irritated perinasal skin area and administration of theformulation for nasal administration into a nostril.

An embodiment of the present invention is directed to a balm holderelement comprising: a base element on which a balm is mounted, a balmcover with a cylindrical portion surrounding the balm, and a coverportion, wherein the balm holder element is attachable to a nasal spraydispenser. In an embodiment, the balm holder element is permanentlyattached to the nasal spray dispenser. In another embodiment, the balmholder is removably attached to the nasal spray dispenser. In anembodiment, the balm holder element is attachable to a bottom of thenasal spray dispenser.

FIGURES

FIG. 1 shows a perspective view of a combination product according to afirst embodiment of the invention;

FIG. 2 shows a perspective view of the combination product of FIG. 1,with a base element of a balm holder element and a balm being removed;

FIG. 3 shows a base element and a balm according to the first embodimentof the invention;

FIG. 4 shows a base element and a balm according to a second embodimentof the invention;

FIG. 5 shows a perspective view of a combination product according to athird embodiment of the invention;

FIG. 6 shows a perspective view of a combination product according to afourth embodiment of the invention with the base element attached to abottom of a container; and

FIG. 7 shows an exploded view of the combination product according tothe first embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The invention will now be described by way of example with reference tothe accompanying figures.

FIGS. 1 to 7 generally depict a combination product which comprises anasal spray dispenser in combination with a balm holder element 30containing a skin-care balm 50 attached to a bottom of the nasal spraydispenser. The phrase “attached to the bottom” should not be understoodas limited to an attachment of the balm cover or the base element to abottom surface of the nasal spray dispenser, but that the balm holderelement can also be attached to a bottom part of the cylindrical wall ofthe nasal spray dispenser.

The nasal spray dispenser containing the formulation may for example bemade from high density polyethylene (HDPE), polypropylene (PP) or glass.Preferably, the nasal spray dispenser is made from HDPE.

FIG. 1 illustrates a nasal spray dispenser comprising a container 20containing a formulation for nasal administration, and a dispensing head10 with a nozzle 12 to be introduced into a nostril covered by a cap 40.In a preferred embodiment, the dispensing head 10 is a metered dosespray pump. Further, FIG. 1 illustrates the balm holder element 30comprising a balm cover 32 and a base element 34 holding the balm 50.

The nasal spray dispenser may be manufactured in one piece or may beassembled from multiple pieces. Preferably, the nasal spray dispensercomprises a dispensing head 10 mounted on a top of a container 20. Inembodiments of the invention, the balm holder element 30 is attached tothe bottom of the container 20.

Preferably, the balm cover 32 corresponds to an outline or shape of thenasal spray dispenser. Therefore, when the nasal spray dispenser has anellipsoid or ovoid outline or shape, the balm cover 32 has acorresponding elliptic or oval cylinder portion. When the nasal spraydispenser has a circular outline or shape, the balm cover 32 has acorresponding circular cylindrical portion.

According to a preferred embodiment of the invention, the balm holderelement 30 comprises a balm cover 32 with a cylindrical portionsurrounding the balm 50 and a cover portion, and a base element 34 onwhich the balm is mounted. Alternatively, the balm holder element 30comprises a balm cover 32 with an elliptic cylinder portion surroundingthe balm and a cover portion, and a base element 34 on which the balm ismounted. Preferably, the balm holder element is made from polypropylene(PP).

FIG. 2 shows the combination product according to an embodiment, withthe base element 34 carrying the balm 50 removed from the nasal spraydispenser. FIG. 3 shows the base element 34 of the embodiment of FIG. 1,together with the balm, separately and ready to be used. In anembodiment, the base element 34 is moulded as one piece and has acircular base plate 37, with a circumferential rim 52 on that base plate37 surrounding the balm 50. In a preferred embodiment, the balm 50 has asubstantially hemispherical shape.

Protrusions protruding inwardly from the circumferential rim 52 can beused to hold the balm 50 in place, once it has been pressed on the baseplate 37 and on the protrusions. Alternatively, the base element 34 andthe balm 50 may be assembled upon moulding of the balm, whereby a moltenbalm formulation solidifies on the base element 34. In the firstembodiment shown in FIGS. 1 and 3, the base element 34 is provided withcircumferential ribs 38 running along parts of the circumference of thebase plate 37 and making it easier to grip the base plate 37 and thusthe base element 34 with the balm 50.

In a preferred embodiment, the balm cover 32 consists of a cylindricalportion 33 surrounding the balm 50, and a cover portion 36 which has adome shape, as can be seen in FIG. 7. The cover portion 36 with its domeshape matches a corresponding recess in the bottom 24 of the container20.

In a preferred embodiment, the cover portion 36 it is glued to thebottom 24 of the container 20. A user can take off the base element 34comprising the balm 50 and apply the balm 50 without having to handlethe nasal spray dispenser, or the container 20 and the dispensing head10 during application. A suitable glue for attaching the balm cover tothe nasal spray dispenser, in particular when the balm cover is madefrom polypropylene (PP) and the nasal spray dispenser is made from highdensity polyethylene (HDPE), is cyano-acrylate glue which is usedtogether with a primer. No heating is necessary to create the bond, andsuch a glue is thus particularly suitable to be used with a pre-fillednasal spray dispenser, where the application of heat in an assemblyprocess could compromise the stability of the formulation contained inthe nasal spray dispenser.

In another embodiment, the balm cover 32 is clipped or snap-fitted tothe bottom of the container 20. On the outer surface of the rim 52,several protrusions 56 are foreseen, which make a snap-fit connectionwith the cylindrical portion 33 of the balm cover 32 and help to keepthe base element 34 connected to the balm cover 32, and thus to thecontainer 20. In a preferred embodiment, the balm cover 32 and the baseelement 34 are made of Polypropylene (PP).

FIG. 4 shows another embodiment of a base element 34′ carrying the balm50. While the overall shape of the base plate 37′ and thecircumferential rim 52′ are the same as for the first embodiment, asshown in FIGS. 1 and 3, the rim 52′ in this embodiment is provided witha thread 54 which matches a thread at the inner circumference of thecylindrical portion of the balm cover (not shown in the figures).Furthermore, in the embodiment shown in FIG. 4, the base element 34′also has ribs 39 on the outer circumference of the circular base plate37′ that are perpendicular to the circumference of the base plate 37′.

FIG. 5 shows an embodiment of a combination product according to anotherembodiment. In this embodiment, a laterally actuated pump 10′, as forexample described in WO2017191205A1, is used. The balm holder element 30is the same as in the embodiment shown in FIGS. 1 and 3.

FIG. 6 shows another embodiment of a combination product according tothe invention, using the same container 20′ and the same laterallyactuated metered dose spray pump 10′, but a different balm holderelement 30″. As can be seen in FIG. 6, the orientation of the balmholder element 30″ is inverted in the embodiment of FIG. 6, with thebase element 34″ being attached to the bottom of the container 20′, andthe balm cover 32″ being removable. In this embodiment, the base element34″ is not glued on a base surface at the bottom of the container, butit comprises a cylindrical portion extending around the lowest part ofthe cylindrical wall 22′ of the container 20′, and can either be gluedthereto, or fixed in another suitable way know in the art, e.g. via asnap-fit or clip connection. The cover portion 36″ of the balm cover 32″is flat, so that the combination product can stand on it.

An example of a balm formulation that may be utilized in the presentinvention is provided in Example 1. Preferably, the formulationcomprises a moisturizing agent, in particular selected from the groupcomprising dexpanthenol, sorbitol and hydroxypropylmethylcellulose.Preferably, the balm comprises an active ingredient having skin soothingproperties, in particular selected from the group comprising ectoin,dexpanthenol, aloe vera, calendula, bisabolol and niacinamide.

In another embodiment, the balm comprises an active ingredient that is abotanical extract. A botanical extract may be an extract from any partof a plant, e.g. an herbal extract. Botanical extracts are widelyaccepted by consumers, can be sourced in an environmentally friendlymanner and do not need to be chemically synthesized. Botanical extractsfrom edible plants are preferred as they are non-toxic and can be usedin the perinasal and perioral area, such as the upper lip region,without limitation. The ingredients of the extracts can be controlledsuch that desired and effective ingredients are enriched and undesirableingredients are reduced or eliminated.

In one embodiment, the botanical extract is Zanthoxylum bungeanum fruithusk extract. This extract is rich in lipophilic alkylamides such ashydroxy-alpha-sanshools and hydroxy-beta-sanshools. These agents arebelieved to act as agonists on receptors of sensory neurons, such as thetransient receptor potential cation channel subfamily V member 1 TRPV1(also known as capsaicin receptor, or vanilloid receptor) and thetransient receptor potential cation channel subfamily A member 1,1TRPA1. The interaction of the ingredients of the extract with thesomatosensory neurons in the skin provides a soothing, numbing andanti-itching effect that is especially suitable for the balm of thepresent invention. It provides a mild tingling effect and gives animmediate relief. Furthermore, it gives a cooling sensation. Itssoothing or paresthesial effect relieves the discomfort of the user,reduces the sensitivity of the skin and reduces the body's response toirritation such as a runny nose, tearing and skin reddening.

Zanthoxylum bungeanum fruit husk extract is not believed to beirritating to the skin and does not cause sensitization. Additionally ithas a pleasant smell that can mask the odour inherent to the other balmcomponents. The balm can therefore be formulated without perfume, whichis preferred as perfumes can cause skin irritation or burning sensation,especially when used on damaged skin.

Preferably, the Zanthoxylum bungeanum fruit husk extract is obtained bya mild, solvent free extraction method such as CO₂ extraction. Thisprovides the advantage of a high yield of the lipophilic alkylamideswith no residual organic solvents.

The Zanthoxylum bungeanum fruit husk extract may typically have acontent of total alkylamides from 4% to 7% by weight and may be used inthe formulation of the balm in an amount from 0.05% to 1.0% by weight.

In another embodiment, the botanical extract comprises Aloe barbadensisleaf extract. Aloe barbadensis leaf extract has a moisturizing effectthat is beneficial for roughened and cracked skin and helps to sootheirritated skin. The Aloe barbadensis leaf extract may be used in theformulation of the balm in an amount from 0.05% to 1% by weight.

Alternatively or in addition to such an active ingredient, the balm cancontain skin conditioning or moisturizing agents or emollients.

Preferably, the balm is a non-aqueous formulation. This reduces the riskof contamination of the balm upon contact with the skin and allows theformulation to be preservative-free. This is beneficial as the balm maybe used on irritated skin with an impaired barrier-function.Furthermore, a non-aqueous formulation forms a waterproof film orbarrier layer on the irritated perinasal skin that has an occlusive,thus hydrating effect and protects the skin from nasal discharge andwiping with tissues that typically exacerbate irritation of the skin.Such a lipophilic film is furthermore preferred as it may serve as asubstitute for a disrupted natural skin barrier and aid to restore thenatural skin barrier which prevents the skin from being damaged further.

The balm formulation preferably comprises a blend of two or more waxesin an amount from 15%-45% by weight of the composition. The use of ablend of two or more waxes lowers the melting point which easesapplication to the skin. The use of a blend also reduces the tendency ofthe waxes to form large crystals, which would make the balm grainy orbrittle.

The terms wax and waxes, as used herein, include waxes and pseudo-waxes.Numerous waxes or pseudo-waxes of animal, plant or petroleum originknown in the art are suitable for the formulation of the balm.Pseudo-waxes are excipients that have physical properties similar tothose of waxes but are not waxes in the chemical sense, i.e. esters offatty acids with fatty alcohols. They may be mixtures of carbohydratesand/or fatty acids and/or fatty alcohols and/or fatty acid esters and/orhydrogenated or unhydrogenated oils (triglycerides). Examples forcarbohydrates are petrolatum and paraffin.

In one embodiment, the balm comprises a blend of petrolatum andparaffin. Petrolatum and paraffin are non-irritating, well-establishedand abundant carbohydrates.

Preferably, the melting point of the balm is in the range of 60° C. to75° C. Melting point is determined according to the method monographedin the European Pharamcopoeia, Method Ph. Eur. 2.2.15. This meltingpoint of the balm reduces the tendency of sweating or creaming of someingredients included in the balm. It also provides firm adhesion of thebalm to the balm base and structural integrity of the balm shape even inwarm temperatures. At the same time, it is still soft enough for easyapplication to the skin and a convenient application on the desiredarea. This melting point is achieved, according to a preferredembodiment, by combining a first wax having a melting point of 70°C.-90° C. and a second wax having a melting point of 30° C.-60° C.

In a preferred embodiment, the first wax is rice bran wax. Rice bran waxgives the balm formulation a matt finish and reduces shine andgreasiness when applied to the skin.

In a preferred embodiment, the balm comprises of a blend of two or morewaxes in an amount of 15%-45% (w/w) and emollients in an amount of45%-70% (w/w). The emollients hydrate the roughened skin of theperinasal area and soothe irritation. Furthermore, emollients reduce thehardness of the balm and lower the crystallization tendency of thewaxes, which makes spreading more gentle and ensures the texture of thebalm remains stable over time. Emollients are well-known in the art.

Preferably, the emollients comprise powdered hydrogenated castor oil.The powdered form of the hydrogenated castor oil reduces shine andgreasiness of the balm when applied to the skin. Examples of othersuitable emollients are botanical butters such as Butyrospermum Parkii(Shea) Butter and Theobroma Cacao (Cocoa) Seed Butter, oils such ascastor oil and avocado oil, octyldodecanol, caprylic/caprictriglyceride, behenyl alcohol, isopropyl lanolate, isopropyl myristate,isocetyl stearate and myristyl myristate.

Emollients comprising unsaturated fatty acids are preferred, for exampleshea butter and/or avocado oil. Avocado oil is especially preferred asit has a specific composition comprising free fatty acids that providesan excellent compatibility with the natural hydrolipidic film on theskin.

The balm may optionally comprise further excipients used in the art suchas antioxidants, wetting agents, matting agents, rheology additives,hydrating agents and cooling agents.

Preferably, the balm has substantially a hemispherical shape, thusallowing for easy application to the desired area.

The balm may be applied to damaged, cracked, roughened, dry andirritated skin. It is especially beneficial for application in theperinasal area, i.e. the skin around the nose and the nostrils and theupper lip region. This area suffers primarily from wiping and noseblowing, nasal discharge, leakage of nasal formulation from the nose andother effects of nasal symptoms. It may also be beneficial forapplication to the perioral area and the lips. The perioral area and thelips also suffer from the effects of nasal symptoms, such as leakage ofnasal formulation or frequent licking.

According to a preferred embodiment, the balm is applied to the skinaround the nose. In another preferred embodiment, the balm is applied tothe skin around the nostrils. The balm may be applied when needed. Forexample, the balm may be applied after each cleaning of the nose ormultiple times daily.

In an embodiment, the formulation for nasal administration may be in apowdered (dry) form. Intranasal administration of powders, and nasalspray dispensers adapted for the intranasal administration of powdersare known in the art. For example, intranasal administration of powderedcellulose derivates is used to block allergens, and intranasaladministration of powdered corticosteroids is used for the treatment ofallergy and asthma. These conditions often cause symptoms such as runnynose, and therefore those formulations are suitable for the presentcombination product.

The formulation for nasal administration may also be a liquidformulation such as a solution or a liquid suspension. Preferably, theformulation for nasal administration is a liquid formulation. Upon nasaladministration of liquid formulations it often occurs that theformulation does not remain in the nose, but flows out of the nostrils.This requires wiping, and may cause skin irritation.

According to a preferred embodiment of the invention, the liquidformulation contains a saline solution and/or an active ingredientselected from the group of vasoconstrictors, antiallergic agents andcorticosteroids.

The nasal administration of saline solutions which may in additioncontain active ingredients is a widely used method of treatment. Activeingredients which come into consideration are, for example,vasoconstrictors, such as xylometazoline, or antiallergic agents, suchas cromoglycic acid or H1 receptor antagonists, e.g. dimethindenemaleate. Another group of possible active ingredients is e.g.corticosteroids, such as beclomethasone or fluticasone.

Examples for formulations for nasal administration are given below inExample 3.

Active substances suitable for nasal administration are e.g.vasoconstrictors, e.g. xylometazoline, e.g. xylometazolinehydrochloride; indanazoline, metizoline; naphazoline, e.g. naphazolinehydrochloride; fenoxazoline, e.g. fenoxazoline hydrochloride;oxymetazoline, e.g. oxymetazoline hydrochloride; tetrahydrozoline,tramazoline, tymazoline; phenylephrine, e.g. phenylephrinehydrochloride; ephedrine, e.g. d-pseudoephedrine hydrochloride; orepine-phrine; or antiallergic agents, such as (1) cromoglycic acid(=cromolyn) or a nasally acceptable salt thereof, e.g. the disodium salt(=disodium cromoglycate), or (2) H1 receptor antagonists, e.g.dimethindene or a nasally acceptable salt thereof, e.g. dimethindenemaleate; acrivastine, brompheniramine, chlorpheniramine,dexchlorpheniramine, triprolidine, bromodiphenhydramine, clemastine,phenyltoloxamine, piprinhydrinate, pyrilamine, tripelennamine,cetirizine, hydroxyzine, methdilazine, promethazine, trimeprazine,azatadine, cyproheptadine, loratadine, astemizole, diphenhydramine,levocabastine or terfenadine. Examples for corticosteroids are e.g.beclomethasone, e.g. beclomethasone dipropionate, or fluticasone, e.g.fluticasone propionate. Mixtures of more than one active substance comealso into consideration, e.g. a combination of a vasoconstrictor and anantiallergic agent, such as xylometazoline plus cromoglycic acid orphenylephrine plus dimethindene, or a combination of a vasoconstrictorand a corticosteroid, such as xylometazoline plus beclomethasone, amongothers.

According to a preferred embodiment, the active ingredient isxylometazoline or a pharmaceutically acceptable salt thereof.Xylometazoline is widely used in particular for treating symptoms ofcommon cold and flu, where the skin irritation and redness issues arisefrequently.

In another embodiment, the active ingredient is oxymetazoline or apharmaceutically acceptable salt thereof. In yet another embodiment, theliquid formulation is a hypertonic saline solution. In still anotherembodiment, the liquid formulation is an isotonic saline solution.

While the invention has been described with reference to an exemplaryembodiment(s), it will be understood by those skilled in the art thatvarious changes may be made and equivalents may be substituted forelements thereof without departing from the scope of the invention. Inaddition, many modifications may be made to adapt a particular situationor material to the teachings of the invention without departing from theessential scope thereof. Therefore, it is intended that the inventionnot be limited to the particular embodiment(s) disclosed, but that theinvention will include all embodiments falling within the scope of theappended claims.

Example 1

The balm may be prepared as indicated below in Table 1. The names of theraw materials are given using the International Nomenclature of CosmeticIngredients (INCI). The % are indicated by weight.

TABLE 1 Example of a balm formulation % of component INCI name of in thefinal component formulation Function of the component OCTYLDODECANOL17.00 EMOLLIENT CAPRYLIC/CAPRIC 14.70 SKIN CONDITIONING TRIGLYCERIDERICINUS 14.30 SKIN CONDITIONING COMMUNIS SEED OIL ORYZA SATIVA 14.00SKIN CONDITIONING CERA SKIN PROTECTING SMOOTHING RHUS 13.40 EMOLLIENTVERNICIFLUA PEEL STABILISING/ CERA/RHUS BINDING SUCCEDANEA EMOLLIENTFRUIT CERA THEOBROMA 7.00 EMOLLIENT CACAO SEED SKIN CONDITIONING BUTTERPERSEA 5.00 SKIN CONDITIONING GRATISSIMA OIL CETEARYL 3.00 EMOLLIENTALCOHOL EMULSIFYING EMULSION STABILISING MYRISTYL 3.00 EMOLLIENTMYRISTATE SKIN CONDITIONING POLYGLYCERYL-3 2.50 EMULSIFYINGDIISOSTEARATE CETYL ESTERS 2.00 EMOLLIENT SKIN CONDITIONINGBUTYROSPERMUM 2.00 SKIN CONDITIONING PARKII BUTTER OLEYL ALCOHOL 0.48EMOLLIENT MASKING ZANTHOXYLUM 0.12 SKIN CONDITIONING BUNGEANUM FRUITEXTRACT TOCOPHERYL 0.50 ANTIOXIDANT ACETATE MENTHYL 0.50 SKINCONDITIONING ETHYLAMIDO OXALATE Eucalyptol Nat 0.2 PERFUMING SKINCONDITIONING MENTHOL 0.20 REFRESHING SOOTHING BHT 0.10 ANTIOXIDANT

Example 2

The balm may be prepared by a conventional method. For example, it isprepared by melting of the solid components in a waterbath at atemperature sufficiently high to melt all ingredients, such as 60°C.-70° C. Subsequently, the liquid ingredients are added and the mixtureis stirred to form a bulk. Any volatile ingredient are added afterletting the bulk cool under stirring, but whilst the bulk is stillfluid. The fluid bulk is poured into a stainless steel mold with anarray of recesses of hemispheric shape. Excess bulk is scraped off. Themold filled with the bulk is let cool down at 5° C. for 20 minutes. Thesolidified balm hemispheres are removed from the mould by turning itupside down and placing it on a hard surface. To produce the combinationproduct, the balm is pressed on the base element 34 and the base elementis assembled with the remaining parts of the balm element and thecontainer that contains the formulation.

Example 3

TABLE 2 Examples for formulations for nasal administration IngredientFunction Amount (% w/w) Example for a liquid formulation comprising acorticosteroid Fluticasone Propionate Active 0.05 Micronised DextroseAnhyrous Osmolarity agent 5 Phenylethyl Alcohol USP Preservative 0.25Avicel RC591 (GI) Suspending agent 1.50 Benzalkonium Chloride EP/Preservative 0.02 USNF/JP Polysorbate 80 (GI) Wetting agent 0.005Purified Water Vehicle Ad 100.0 Example for a liquid formulationcomprising a vasoconstrictor Xylometazoline Hydrochloride ActiveIngredient 0.1 Sodium dihydrogen phosphate Buffering Agent 0.28dihydrate Disodium phosphate Buffering Agent 0.3 dodecahydrate Disodiumedetate Chelating agent 0.05 Benzalkonium Chloride Preservative 0.01Sodium Chloride Isotonicity regulator 0.7 Purified water Vehicle Ad 100Example for a liquid formulation comprising a vasoconstrictor and amoisturizing agent Oxymetazoline Hydrochloride Active Ingredient 0.05Sodium dihydrogen phosphate Buffering Agent 0.2 dihydrate Disodiumphosphate Buffering Agent 0.28 dodecahydrate Disodium edetate Chelatingagent 0.05 Benzalkonium Chloride Preservative 0.01 Sorbitol 70%(non-crystallising) Moisturizing Agent 1.4 Sodium Chloride Isotonicityregulator 0.5 Levomenthol Aroma 0.03 Cineol Aroma 0.02 Castor oil,polyoxyl Solubiliser 0.275 hydrogenated Purified water Vehicle ad 100

1. A combination product comprising a nasal spray dispenser containing aformulation for nasal administration, and a balm holder elementcontaining a skin-care balm, attached to a bottom of the nasal spraydispenser.
 2. A combination product according to claim 1, wherein thebalm holder element is detachably attached to the bottom of the nasalspray dispenser.
 3. A combination product according to claim 1, whereinthe nasal spray dispenser comprises a dispensing head mounted on a topof a container.
 4. A combination product according to claim 3, whereinthe dispensing head is a metered dose spray pump.
 5. A combinationproduct according to claim 1, wherein the balm holder element comprisesa base element on which the balm is mounted, a balm cover with acylindrical portion surrounding the balm, and a cover portion.
 6. Acombination product according to claim 5, wherein the cylindricalportion of the balm cover is aligned with a cylindrical wall of thenasal spray dispenser.
 7. A combination product according to claim 5,wherein the cover portion of the balm cover is attached to the bottom ofthe nasal spray dispenser.
 8. A combination product according to claim7, wherein the cover portion of the balm cover is glued to the bottom ofthe nasal spray dispenser.
 9. A combination product according to claim7, wherein the cover portion is dome-shaped and matches a recess in thebottom of the nasal spray dispenser.
 10. A combination product accordingto claim 7, wherein the cover portion of the balm cover is clipped orsnap-fitted to the bottom of the nasal spray dispenser.
 11. Acombination product according to claim 5, wherein the base element ofthe balm holder element is attached to the bottom of the nasal spraydispenser.
 12. A combination product according to claim 1, wherein theformulation is a liquid formulation containing a saline solution.
 13. Acombination product according to claim 1, wherein the formulation is aliquid formulation containing an active ingredient selected from a groupof vasoconstrictors, antiallergic agents, and corticosteroids.
 14. Acombination product according to claim 13, wherein the active ingredientis xylometazoline or a pharmaceutically acceptable salt thereof.
 15. Acombination product according to claim 1, wherein the balm comprises anactive ingredient that is a botanical extract.
 16. A combination productaccording to claim 1, wherein the balm comprises one or several skinconditioning agents.
 17. A combination product according to claim 1,wherein the balm has substantially a hemispherical shape.
 18. A balmholder element comprising: a base element on which a balm is mounted, abalm cover with a cylindrical portion surrounding the balm, and a coverportion, wherein the balm holder element is attachable to a nasal spraydispenser.
 19. A method for treating nasal discomfort whereby a coolingand soothing effect is provided to a perinasal skin area, comprising useof a combination product according to claim 1 by application of the balmto the perinasal skin area and administration of the formulation fornasal administration into a nostril.
 20. A method for treating runnynose whereby irritated skin is soothed, comprising use of a combinationproduct according to claim 1 by application of the balm to an irritatedperinasal skin area and administration of the formulation for nasaladministration into a nostril.